Status:
COMPLETED
Mitochondrial Biomarkers in Huntington's Disease
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Case Western Reserve University
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Huntington Disease
Eligibility:
All Genders
20-85 years
Brief Summary
The objective of this study is to discover a panel of mitochondrial metabolomics biomarkers for Huntington's disease.
Detailed Description
This investigator-initiated, single-site longitudinal study seeks to assess the utility of mitochondrial metabolomics -- panels of small molecules that affect mitochondrial function -- to diagnose pre...
Eligibility Criteria
Inclusion
- Age 20 to 85
- Montreal Cognitive Assessment score \>10
- HD subjects had onset of HD symptoms after the age of 20
- HD subjects with Diagnostic Confidence Level (DCL) of 0-3 (pre-symptomatic or pre-manifest) must have at least 40 CAG repeats on one HTT allele
- HD subjects with Diagnostic Confidence Level (DCL) of 4 (manifest) must have at least 36 CAG repeats on one HTT allele
- Controls are asymptomatic without family history of HD or have \<36 CAG repeats on both HTT alleles with family history of HD
Exclusion
- HD subjects who did not already have genetic testing are excluded from this study
- Pregnancy or plans to become pregnant during the study
- Investigational drugs within 3 months of screening visit
- Alcohol or illicit drug abuse or dependence
- Other genetic or neurological disorders
- Other medical or psychiatric illness that in the investigator's judgement will prevent ability to tolerate or undergo study procedures
- For those volunteering for lumbar puncture (LP), bleeding disorders or excessive bleeding, anticoagulation, aspirin if unable to safely stop taking it at least 7 days prior to LP, other antiplatelet medications, inability to tolerate LP, allergy to local anesthetic or chlorhexidine, major lumbar spine deformity, low platelets or abnormal coagulation factors PT/APTT
Key Trial Info
Start Date :
April 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04515550
Start Date
April 4 2019
End Date
February 28 2022
Last Update
April 12 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106